The following data is part of a premarket notification filed by Utak Laboratories, Inc. with the FDA for Trace Elements Serum Toxicology Control.
| Device ID | K883147 |
| 510k Number | K883147 |
| Device Name: | TRACE ELEMENTS SERUM TOXICOLOGY CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | UTAK LABORATORIES, INC. 26752OAK AVENUE, SUITE J Canyon Country, CA 91351 -2409 |
| Contact | Lawrence B Plutchak |
| Correspondent | Lawrence B Plutchak UTAK LABORATORIES, INC. 26752OAK AVENUE, SUITE J Canyon Country, CA 91351 -2409 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-26 |
| Decision Date | 1988-10-06 |